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DIA 2021 Global Annual Meeting
COVID-19 Real-World Data Analysis and Vaccine Surveillance: Examples from FDA and The Danish Medicines Agency’s Approaches
Session Chair(s)
Jesper Kjær, MS
- Co-Chair, EMA/HMA Big Data Steering Group; Director of Data Analytics Centre
- Danish Medicines Agency (DKMA), Denmark
This session will include presentations of the Danish Medicines Agency's COVID-19 cohort data analyses, the FDA’s N3C Data Enclave and the vaccine surveillance on COVID-19 patients using real-world data (RWD) from registries as examples of regulatory use of RWD during the COVID-19 pandemic.
Learning Objective : Describe the novel use of real-world data (RWD) during the COVID-19 pandemic; Describe, discuss, and evaluate the different opportunities and challenges in use of RWD given different healthcare settings and access to healthcare data.
Speaker(s)

DAC COVID: Exemplified by the Most Recent Analysis on Post-Acute Effects of Covid 19
Stine Hasling Mogensen, MPharm
- Senior Scientific Advisor
- Danish Medicines Agency, Denmark
Arterial Events, Venous Thromboembolism, Thrombocytopenia, and Bleeding After Vaccination in Denmark and Norway: Population-Based Cohort Study
Anton Pottegaard, DrSc, PhD, MPharm
- Head of Research at the Hospital Pharmacy; Professor
- University of Southern Denmark, Denmark
Off-Label Use Monitoring Through Danish Registries
Mona Vestergaard Laursen, MPharm
- Senior Advisor, Data Analytics Centre
- Danish Medicines Agency, Denmark
FDA Real-World Evidence Activities Related to Covid19
Mitra Rocca, MSc
- Associate Director, Medical Informatics, Office of Translational Science, CDER
- FDA, United States
COVID-19 Real-World Data Analysis and Vaccine Surveillance: Examples from FDA and Their Novel Approach to Rapid Safety Surveillance
Richard Forshee, PhD
- Deputy Director, OBPV CBER
- FDA, United States